Clinical Research Directory

Inclusion Criteria: * Patient is ≥18 years old * Patient presenting a score from 2 to 4 following Rutherford classification * Patient is willing to comply with specified follow-up evaluations at the specified times * Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * Patient has a life expectancy of at least 12 months * Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation * De novo stenotic or restenotic (post-PTA) lesions (\<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy * Target lesion is located within the native CFA: localized between 1cm proximal to the origin of the circumflex iliac artery and the proximal (2cm) superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions) * There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery * The target lesion has angiographic evidence of \>50% stenosis. Occlusions are not allowed. Exclusion Criteria: * Presence of another stent in the target vessel that was placed during a previous procedure * Previous open surgery in the ipsilateral groin * Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics * Patients who exhibit persistent acute intraluminal thrombus at the target lesion site * Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II * Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure * Patients with uncorrected bleeding disorders * Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding * Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis \>30% * Use of thrombectomy, atherectomy or laser device during procedure * Any patient considered to be hemodynamically unstable at onset of procedure * Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy * Major distal amputation (above the ankle) in the study limb or non-study limb * Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm) * Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications * Presence of an aortic, iliac or femoral artificial graft * Occlusion in the target lesion * Presence of an interposition graft with/without profunda reimplantation